MANUFACTURING AND SUPPLY AGREEMENT

Exhibit 10.1

MANUFACTURING AND SUPPLY AGREEMENT

This MANUFACTURING AND SUPPLY AGREEMENT (this “ Agreement ”), effective as of August 19, 2008 (the “ Effective Date ”), is made by and between NeurogesX Inc. , a Delaware California corporation having a principal place of business at 2215 Bridgepointe Parkway, Suite 200, San Mateo, California 94404 U.S.A. (“ NeurogesX ”), and Formosa Laboratories , Inc., a Taiwanese corporation having a principal place of business at 36-1 Hoping Street, Louchu County, Tauyuan, Taiwan 338 (“ Supplier ”). NeurogesX and Supplier may be referred to herein each, individually, as a “ Party ” or, collectively, as the “ Parties ”.

BACKGROUND

A. NeurogesX has developed and is currently in the process of seeking marketing approval for a product which incorporates trans-capsaicin (the “API” as further defined below) for the treatment of neuropathic pain.

B. Supplier has developed methods for and has experience and know how in manufacturing API under GMP conditions.

C. NeurogesX desires to engage Supplier, and Supplier desires to perform, the manufacturing and supply of such API in bulk form for NeurogesX, all on the terms and conditions set forth herein.

NOW THEREFORE, for and in consideration of the covenants, conditions, and undertakings hereinafter set forth, it is agreed by and between the Parties as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following capitalized terms shall have the meanings indicated below:

1.1 “ Act ” shall mean the United States Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder, as such may be amended from time to time.

1.2 “ API ” shall mean the Active Pharmaceutical Ingredient as set forth in the Specifications. An API is any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of humans or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

1.3 “ Approval ” shall have the meaning as set forth in Section 7.1 below.

1.4 “ Batch Log Records ” shall mean all documentation and records related to the manufacturing process for each batch of API.

1.5 “ Confidential Information ” shall have the meaning as set forth in Section 10.1 below.

1.6 “ Deliverables ” shall mean the test results, reports and other items that Supplier is obligated to provide to NeurogesX pursuant to a Proposal.

1.7 “ Documentation ” shall mean all written materials generated in connection with the Services, including the Batch Log Records, Master Production Record, test results, Certificate of Analysis (“CoA”), analytical test methods, reports, protocols and any other documents related to the manufacturing process for the API, as well as such other documents reasonably necessary for NeurogesX to complete its regulatory filings.

1.8 “ Facility ” shall mean Supplier’s GMP manufacturing facility located at [***].

1.9 “ FDA ” shall mean the United States Food and Drug Administration, or any successor agency thereto.

1.10 “ GLP ” shall mean good laboratory practice.

1.11 “ GMP ” shall mean current good manufacturing practice and standards as provided for (and as amended from time to time) in the Current Good Manufacturing Practice Regulations of the U.S. Code of Federal Regulations Title 21 (21 CFR § 11, § 210 and § 211) and in European Community Directive 2004/27/EC and 2004/28/EC (Principle and guidelines of good manufacturing practice for medicinal products) in relation to the production of pharmaceutical products, as interpreted by the ICH Harmonized Tripartite Guideline, any U.S., European, or other applicable laws, regulations or respective guidance documents subsequently established in the Territory, and any arrangements, additions or clarifications agreed from time to time between the Parties.

1.12 “ LTS ” shall mean Loehmann Therapie-Systeme AG and its subsidiaries.

1.13 “ Master Production Record ” shall mean the certain documents approved by NeurogesX that define the manufacturing methods and procedures, test methods, specifications, materials, and other procedures, directions and controls associated with the manufacture and testing of API.

1.14 “ NeurogesX Property ” shall have the meaning set forth in Section 6.2 below.

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1.15 “ Quality Agreement ” shall mean that certain Commercial Quality Assurance Agreement between the Parties dated June 7, 2006, which is attached hereto as Exhibit A and as such may be modified pursuant to the terms set forth therein.

1.16 “ Raw Materials ” shall mean all raw materials, supplies, components and packaging necessary to manufacture the API in accordance with the Specifications and Master Production Record.

1.17 “ Regulatory Requirements ” shall mean (i) compliance with all applicable laws, rules, guidelines, regulations and standards of governmental authorities, including GMP, and (ii) obtaining and maintaining all licenses and other authorizations required by regulatory authorities, that in each case are applicable to the manufacturing, processing, and supply activities hereunder, the Facility, or any other facilities at which any of the manufacturing or process activities hereunder may be performed or are applicable in the Territory.

1.18 “ Services ” shall mean the development, validation, and/or other services performed by Supplier pursuant to a Proposal.

1.19 “ Specifications ” shall mean with respect to API, the specifications set forth on Exhibit B hereto, as such may be modified pursuant to Section 3.5 below.

1.20 “ Supplier Background Technology ” shall mean all patent rights, know-how and other intellectual property rights developed by Supplier outside the scope of this Agreement (including outside the scope of any Services) without use of or reference to NeurogesX’ Confidential Information, or otherwise acquired or licensed by Supplier, in each case to the extent controlled by Supplier as of the Effective Date or at any time during the term of this Agreement.

1.21 “ Proposal(s) ” shall have the meaning set forth in Section 4.1 below, as such may be modified pursuant to Section 4.3 below.

1.22 “ Territory ” shall mean [***].

1.23 “ $ ” shall mean the lawful currency of the United States of America.

ARTICLE 2

SUPPLY

2.1 API Supply . Subject to the terms and conditions of this Agreement, Supplier shall supply to NeurogesX all quantities of the API ordered by NeurogesX under this Agreement. Supplier shall supply to NeurogesX the API in kilogram orders, but shall not supply the API by aggregating the excess API of batches manufactured by Supplier for third party clients. In addition, NeurogesX has the exclusive right to purchase any full batch manufactured solely for NeurogesX by submitting an Order pursuant to Section 2.4 below. In addition, Supplier shall use its best efforts to fulfill the Orders using as few manufacturing runs as possible.

2.2 Raw Materials . Supplier shall be responsible, at its expense, for procuring, inspecting and releasing adequate amounts of Raw Materials from vendors approved by NeurogesX, to meet NeurogesX’ purchase orders, unless otherwise agreed to by the Parties in

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writing. NeurogesX approval of vendors shall not be unreasonably withheld or delayed. NeurogesX reserves the right to require the Supplier to purchase Raw Materials from a particular vendor at a reasonable price upon prior written notice of twelve (12) weeks. If the required change of vendor results in a cost increase of Raw Materials and as a consequence causes the Batch Prices of API, as stated in Exhibit D attached hereto, to increase more than [***], NeurogesX shall be responsible for that equivalent increase in the Batch Prices of API. Further, Supplier shall conduct tests on each Raw Material and shall provide NeurogesX with the results of such tests. Such tests include, but are not limited to quality tests to determine the purity, impurity, presence of any heavy metals and tests to identify the raw materials of the API.

2.3 Forecasts . At least [***] before the commercial launch of the API or a product incorporating the API (such product a “ Product ”), NeurogesX shall provide Supplier with an initial forecast of the quantities of API estimated to be required from Supplier during the four (4) calendar quarter periods following such launch. Thereafter, at least ninety (90) days prior to each calendar quarter (“ Q1 ”), NeurogesX will provide Supplier with a rolling forecast of the quantities of API estimated to be required during Q1 and the next three (3) calendar quarters (“ Q2 ”, “ Q3 ” and “ Q4 ”, respectively). For clarity, all forecasts provided to Supplier under this Section 2.3 are for advisory purposes, with the exception of Q1 demand which will be binding.

2.4 Orders . NeurogesX’ orders for API shall be made pursuant to a written purchase order on its standard form specifying the desired quantity of API (each an “ Order ”), and will provide for shipment in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by Supplier and NeurogesX so long as the minimum lead time shall be at least [***] and a maximum lead time of [***] unless otherwise agreed to by the Parties. In the event that the actual quantity of Raw Materials required to fulfill NeurogesX’s purchase order falls short of the quantity of Raw Materials ordered by the Supplier pursuant to written purchase order, [***] shall bear the difference between Raw Material payments for the actual purchase order quantities. Such payment can be credited against the next Order for API as prepayment from [***]. NeurogesX shall exercise its ability, if desired, to purchase full batches at the time the Order is made. ANY ADDITIONAL OR INCONSISTENT TERMS OR CONDITIONS OF ANY PURCHASE ORDER, ACKNOWLEDGMENT OR SIMILAR STANDARDIZED FORM GIVEN OR RECEIVED PURSUANT TO THIS AGREEMENT WILL HAVE NO EFFECT AND SUCH TERMS AND CONDITIONS ARE HEREBY EXCLUDED UNLESS THE PARTIES SPECIFICALLY AGREE IN WRITING FOR SUCH TERMS OR CONDITIONS TO SUPPLEMENT OR SUPERCEDE THE TERMS AND CONDITIONS OF THIS AGREEMENT.

2.5 Packaging . API shall be shipped packaged in containers in accordance with the applicable Specifications or as otherwise agreed by the Parties in writing. Each such container will be individually labeled in accordance with any regulatory requirements which may include a description of its contents, including the manufacturer lot number, quantity of API, and expiration date and/or retest date.

2.6 Delivery . Supplier shall deliver the quantities of API ordered by NeurogesX on the dates specified in NeurogesX’ purchase orders submitted in accordance with Section 2.4 above. All API shall be delivered C.I.P. (Incoterms 2000) to named place of destination. Upon Supplier’s delivery of the API, C.I.P. place of destination, NeurogesX will bear all risk of loss,

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delay, or damage. [***] shall select the carrier. All API delivered hereunder shall be suitably packed for shipment by Supplier in accordance with good commercial practice, and instructions provided to Supplier by NeurogesX, with respect to protection of such API during transportation and marked for shipment to NeurogesX’ specified receiving point.

2.7 Cost Reduction . The Parties will participate in cost reduction projects pertaining, but not limited to, the manufacture and supply of API for NeurogesX. If a Party identifies a potential cost reduction measure, the identifying Party shall disclose the details to the other Party so that both Parties can evaluate whether such measure should be implemented and agree upon the costs of implementing such measure and the resulting cost savings. In the event the Parties agree on implementing a cost saving measure, the Parties agree to come together and discuss who will pay for the cost implementation and negotiate how to share the cost savings and the Parties shall adjust the price of the API and revise Exhibit D accordingly.

2.8 Shortage of Supply of API . Supplier shall promptly notify NeurogesX if Supplier has any reason to believe that it may be unable to deliver API in accordance with NeurogesX’ purchase orders to the extent that Supplier is obligated to supply API hereunder, including if Supplier is experiencing manufacturing difficulties that it believes create a reasonable possibility of disrupting supply in the future. In such event, the Parties shall meet and cooperate reasonably in order to formulate a plan in an effort to avoid any such disruption, such plan may include Supplier or NeurogesX identifying potential backup suppliers of API (each, an “ Alternate Supplier ”) or NeurogesX manufacturing the API.

ARTICLE 3

QUALITY

3.1 Quality . All API supplied by Supplier shall meet the Specifications (as may be amended) and shall be manufactured, packaged, tested and stored at the Facility in accordance with the Quality Agreement, all applicable Approvals and Regulatory Requirements, including GMP manufacturing and record keeping procedures.

3.2 Quality Control . Prior to each shipment of API, Supplier shall perform quality control testing procedures and inspections to verify that the API to be shipped conforms fully to the Specifications, as set forth in the Quality Agreement. Each shipment of API shall be accompanied by a Certificate of Analysis (“CoA”) issued by the Supplier, in a form agreed upon with NeurogesX, describing all current requirements of the Specifications, results of test performed certifying that the API supplied have been manufactured, controlled and released at the Facility in accordance with the Specifications, all Approvals and applicable Regulatory Requirements. In the event of a dispute between the parties over a GMP issue(s), NeurogesX and Supplier agree to submit the issue to a mutually agreed upon independent consultant, and the consultant’s opinion shall be binding upon the both parties in regards to that GMP issue(s). The expense of obtaining the independent consultant’s binding opinion shall be borne by the losing Party.

3.3 Acceptance . Acceptance by NeurogesX of API manufactured by Supplier shall be subject to inspection and applicable testing, by NeurogesX or its designee as set forth in the Quality Agreement and Exhibit E. If on such inspection or testing, NeurogesX or its designee

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discovers that any API fails to conform with the Specifications, any GMP requirements, any Regulatory requirements, or otherwise fails to conform to the warranties given by Supplier in Section 8.1 below, NeurogesX or such designee may reject such API, which rejection will be accomplished by giving written notice to Supplier that specifies the manner in which the API fails to meet the foregoing requirements. Upon request from Supplier, NeurogesX shall return the rejected API in accordance with Supplier’s reasonable instructions at Supplier’s expense, provided that such instructions comply with all applicable laws, regulations and Regulatory Requirements. [***]. Supplier shall [***] replace rejected API within the shortest possible time within [***] after Supplier’s receipt of notice thereof provided materials are available, and in any event within [***]. The replacement of rejected API shall have priority over the supply of API ordered for shipment not more than [***] before, or any time after, the rejection of such nonconforming API. If an API shipment or part thereof is rejected before the date on which payment is due therefor, NeurogesX may withhold payment for such shipment or the rejected portion thereof. If an API shipment or portion thereof is rejected after payment, NeurogesX may credit the amount paid therefor against other amounts due to Supplier hereunder. [***]. The warranties given by Supplier in Section 8.1 below shall survive any failure to reject by NeurogesX under this Section 3.3.

3.4 Latent Defects . As soon as either Party becomes aware of any defect in any API that is not discoverable upon a reasonable inspection or quality control testing as set forth in the Specifications (“Latent Defect”), but in no case later than thirty (30) days after reaching such awareness, it shall immediately notify the other Party, and both parties shall determine as to the responsibility of such Latent Defect pursuant to Section 3.3. Supplier will only be responsible for Latent Defects resulting from any deviation from the manufacturing process on the part of Supplier including any deviation from the terms, conditions and/or specification(s) outlined in the Quality Assurance Agreement, reasonably demonstrated, relative to its manufacturing, packaging, and testing services responsibilities according to this Agreement. Any Latent Defect solely related to compatibility issues will not be the financial responsibility of Supplier. The term “compatibility issues” as used in this Section 3.4 shall mean a previously unknown chemical reaction between the API or Product’s chemical components and packaging.

3.5 Changes to the Specifications . Any changes to the Specifications will be made in accordance with the Quality Agreement.

3.6 Lot Records; Samples . Supplier shall maintain lot records in accordance with the Quality Agreement. Subject to the foregoing, Supplier shall notify NeurogesX before disposing of any of the foregoing, and NeurogesX shall have the option of having such records and samples delivered to NeurogesX or its designee. Upon the request of NeurogesX, Supplier shall provide NeurogesX reasonable access to and copies of such records and samples at NeurogesX’ expense.

ARTICLE 4

SERVICES

4.1 Scope of Services . From time to time during the term of this Agreement, NeurogesX may request and Supplier may agree to perform certain services for NeurogesX relating to the API or its manufacture (the “Services”), all as described in one or more mutually

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agreed proposals which shall be attached hereto as Exhibit C (each, a “ Proposal ”). Such services may include, but are not limited to on-going batch stability studies for NeurogesX and future product development. Each Proposal shall be numbered consecutively (for example, the initial Proposal would be Proposal #1 and set forth in detail the Services to be performed by Supplier, including without limitation, the timeline for delivery of reports and other Deliverables, the fees to be charged, and the like). The Parties may modify Exhibit C hereto to revise an existing Proposal pursuant to Section 4.3 below or otherwise add a new Proposal, provided, that no Proposal, or any modification thereto, shall be attached to or made a part of this Agreement without first being executed by the Parties hereto in writing which specifically references this Agreement.

4.2 Standards of Performance . Supplier will use [***] to perform Services and deliver to NeurogesX the completed Deliverables, all in accordance with the respective Proposal, including without limitation, the specifications and the timelines set forth therein. All Services shall be conducted in a good, scientific manner in compliance with all applicable Regulatory Requirements, GLP, laws and regulations.

4.3 Changes to Proposals . NeurogesX may, at any time, submit to Supplier a request for changes to any Proposal. NeurogesX agrees to pay Supplier the reasonable costs associated with such change, as [***] in advance [***] in writing. Supplier shall use its [***] to make all changes requested by NeurogesX, and to minimize the time and additional charges required as a result of such changes. Without limiting the foregoing, if Supplier can implement the requested changes without resulting in increases in Supplier’s time or cost, and without affecting Supplier’s ability to meet the Services timeline as set forth in such Proposal, Supplier shall implement such changes in accordance with such timeline at no additional cost to NeurogesX.

4.4 Acceptance of Deliverables under a Proposal . Supplier shall timely deliver to NeurogesX or its designee each Deliverable resulting from the Services. Acceptance by NeurogesX of such Deliverables shall be subject to inspection and other testing by NeurogesX or its designee. If on such inspection or testing NeurogesX or its designee discovers that the Deliverable fails to conform to the applicable specifications, NeurogesX or such designee may reject such Deliverable upon written notice. Upon request from Supplier, NeurogesX shall return the rejected Deliverable in accordance with [***], provided that such instructions comply with applicable laws, regulations and Regulatory Requirements. If NeurogesX rejects a Deliverable, Supplier shall promptly correct the failure(s) specified in the rejection notice and re-deliver to NeurogesX, at Supplier’s cost and expense (including re-delivery costs), a replacement Deliverable that meets the applicable specifications, for acceptance testing under this Section 4.4. If Supplier disagrees with NeurogesX’ determination, the Parties agree to proceed according to Section 3.3 above.

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4.5 Reporting/Transfer of Results .

(a) In connection with the Services and as applicable, Supplier will provide NeurogesX with regular written reports, as part of the Deliverables or as requested by NeurogesX, and a final written report upon completion of each Service, of all results and NeurogesX IP developed or generated during the course of the Services. Supplier shall provide reasonable assistance to NeurogesX in NeurogesX’ efforts to understand and use the information contained in such reports. Supplier agrees that the first time Supplier provides any information in such reports that Supplier believes to be Supplier Background Technology or Supplier Improvements, such information shall be fully described in a separate section in such report.

(b) Supplier will also respond to NeurogesX’ reasonable inquiries, at Supplier’s expense, regarding the status of the Services on an ongoing basis, and Supplier will endeavor to keep NeurogesX reasonably informed of interim results on an informal basis, including, if requested, periodic meetings at Supplier’s facility to discuss results and progress of the Services, and Supplier will follow any reasonable instructions or direction of NeurogesX with regard to the Services.

ARTICLE 5

PAYMENTS

5.1 API Orders .

(a) Price . The price to be paid by NeurogesX per kilogram (kg) of API ordered by NeurogesX shall be as set forth on Exhibit D hereto. The parties agree [***] may be made by [***] during the term of this Agreement based on [***]; provided, however [***] measured at the beginning of such [***]. Further adjustments may be made to price to account for changes in the quantity of API to be supplied or applicable run sizes, provided that such increases are agreed by NeurogesX in advance. Also, price adjustments may occur upon modifications to the Specifications requested by either Party to the extent of any [***] resulting from such changes in Specifications, consistent with Sections 2.7 and 3.5.

(b) [***]

(c) Invoicing; Payment . In accordance with the flow chart in Exhibit E attached hereto, Supplier shall submit the first invoice to NeurogesX for [***] of the Order cost after completing the manufacturing run, generating the CoA and Certificate of Compliance and submitting Batch Documentation to NeurogesX. Supplier shall submit the second invoice to NeurogesX for [***] of the Order cost upon NeurogesX approval of manufacturing release. In addition, if NeurogesX is unable to approve the release for shipping within 60 days of approval of manufacturing release, NeurogesX shall be responsible for any and all storage fees pursuant to GMP. Supplier shall submit a third invoice to NeurogesX for [***] of the Order cost upon NeurogesX confirmation that the Order meets the specifications based on a NeurogesX approved third party’s documentation and CoA. All invoices will be sent to the address specified in the applicable Order, and each invoice will state the aggregate and unit price for API in a given shipment, plus any taxes, or other costs incident to the purchase by NeurogesX under this Agreement. All payments pursuant to this Agreement, or an Order shall be made by wire transfer in U.S. dollars within [***] of NeurogesX’ receipt of the invoice.

(d) Currency Fluctuation . The currency exchange rate between the US dollar and Taiwan dollar shall be set at the market rate at the end of the trading day on the Effective Date of this Agreement. In the event that the exchange rate between the two currencies

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fluctuates more than [***] between the Effective Date and the date an Order is submitted to Supplier, NeurogesX and Supplier agree that the percentage change in the currency exchange shall be equally split between the Parties. Solely for clarity and example purposes, if the US dollar [***] in value relative to the Taiwan dollar between the Effective Date and an Order date, NeurogesX would agree to pay the contract amount [***] of the contract amount to account for the US dollar value decrease.

5.2 Services . In consideration for the Services performed by Supplier, NeurogesX agrees to pay to Supplier in U.S. dollars by wire transfer the amounts set forth in the applicable Proposal in accordance with the terms and conditions set forth therein.

ARTICLE 6

OWNERSHIP AND LICENSES

6.1 Background IP . Each Party shall retain all right, title and interest in and to all inventions (whether or not patentable), discoveries, technology and know-how (collectively, “ Inventions ”) that are owned or controlled by such Party as of the Effective Date or developed and/or acquired by such Party entirely independently and outside of this Agreement after the Effective Date.

6.2 NeurogesX Property . NeurogesX shall own all data, documents, protocols, and materials created, reduced to practice or compiled by Supplier in the course of performing Services that are based on NeurogesX’ Confidential Information (collectively, the “NeurogesX Property”).

6.3 Supplier Technology . Pursuant to Section 6.1, Supplier shall own all right, title and interest in and to the Supplier Background Technology and all improvements and modifications thereto, which improvements are of a general nature, performed independently, without use of or reference to NeurogesX’ Confidential Information, including for example, standard operating procedures, software or laboratory methodologies (the “ Supplier Improvements ”).

ARTICLE 7

REGULATORY MATTERS

7.1 Regulatory Approvals . NeurogesX, itself or through its agents, shall have the right to correspond with and submit regulatory applications and other filings to the FDA or other regulatory authorities to obtain approvals to import, export, sell, or otherwise commercialize the API alone or with other products (each, an “ Approval ” and collectively, “ Approvals ”) as NeurogesX deems useful or necessary, however, NeurogesX agrees that it shall not, sell or otherwise commercialize the API other than as a component of a product. Except as otherwise required by law, Supplier shall not correspond directly with the FDA or any other regulatory agency relating to the process of obtaining Approvals or any obtained Approval for the API without NeurogesX’ prior consent. [***]. Not withstanding the foregoing, Supplier may maintain its own Drug Master File (DMF) with the FDA. Supplier agrees to allow NeurogesX, its affiliates and sublicensees to reference any DMF filed with the FDA related to the API and/or NeurogesX’s commercialization efforts.

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Information . Without limiting Section 7.1 above, Supplier shall promptly provide NeurogesX all written and other information, other than information developed for other Supplier clients and subject to a confidentiality obligation, in Supplier’s possession or control that is necessary or useful for NeurogesX to apply for, obtain, and maintain Approvals for a product, which incorporates the API, including without limitation, Documentation, information relating to the Facility, process, methodology, or components used in the manufacture, processing, or packaging of the API or other information required to be submitted to the FDA or other regulatory authorities in the form of a marketing application or to support a post-approval change. In addition, Supplier shall immediately inform NeurogesX when any such information is no longer current and reflective of current manufacturing practices, procedures, or the Specifications and provide updated information to NeurogesX through agreed channels for managing change according to the Quality Agreement.

Inspections . Supplier shall permit the FDA and other regulatory authorities to conduct inspections of the Facility as the FDA or other regulatory authorities may request, and shall cooperate with the FDA or other regulatory authorities with respect to the inspections and any related matters, in each case relating to the API. Supplier shall give NeurogesX prior notice, to the extent practicable, of any such inspections, and keep NeurogesX informed about the results and conclusions of each regulatory inspection, including actions taken by Supplier to remedy conditions cited in the inspections. Responses to any 483 observations (or equivalent observations from other Regulatory Authorities) that directly relate to API have to be approved by NeurogesX before they are submitted. In addition, Supplier shall allow NeurogesX or its representative to assist in the preparation for and be present at the inspections to participate in discussion directly related to the API or its manufacture. Supplier will provide NeurogesX with copies of any written inspection reports issued by the regulatory agency and all correspondence between Supplier and the regulatory agency, including, but not limited to, FDA Form 483, Notice of Observation, and all related correspondence, in each case relating to the API or general manufacturing concerns (i.e., facility compliance or the like). NeurogesX and its regulatory consultants, agents, marketing partners, and other third parties, under reasonable confidentiality requirements, shall have access to all regulatory and quality assurance GMP audits of Supplier to assess regulatory compliance and to the buildings, records, and areas of the Facility or other facilities involved in the manufacture, testing, storage, and shipment of the API.

7.2 Maintenance of Approvals . Notwithstanding anything in the Agreement to the contrary, Supplier shall not undertake any modifications to the API manufacturing or testing processes or use any subcontractors or vendors in any way that could delay or otherwise impact the Approvals or other regulatory submissions, including without limitation, regulatory product reviews, Investigational New Drug applications (INDs), New Drug Applications (NDAs), or any other compliance status without the prior written agreement of NeurogesX.

7.3 Reporting . Pursuant to the FDA’s and other applicable regulatory agency’s regulations and policies, NeurogesX may be required to report information that reasonably suggests that an API may have caused or contributed to the death or serious injury. Accordingly, Supplier shall inform NeurogesX of any such information promptly after becoming aware of it so that NeurogesX can comply with such reporting requirements.

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7.4 Records . Supplier shall maintain adequate and accurate records covering the manufacture, stability programs, quality control testing, storage and release of API supplied hereunder and all other Services provided hereunder, in accordance with GMPs and all Regulatory Requirements, for as long as required under applicable laws and regulations, and then for a period of [***] thereafter. Supplier will make such records available to NeurogesX, its designees and regulatory agencies as requested by NeurogesX, at no additional cost to NeurogesX. Subject to the foregoing maintenance requirement, Supplier shall notify NeurogesX before destroying any such records, and NeurogesX shall have the option of having such records delivered to NeurogesX or its designee at NeurogesX’ cost.

ARTICLE 8

PRODUCT WARRANTIES

8.1 Supplier Product Warranties . Supplier represents and warrants that:

(a) Specifications . All API supplied hereunder shall comply with the Specifications shown on the CoA provided for the particular shipment pursuant to Section 3.2 above;

(b) Regulatory Requirements . The Facility, the manufacturing and supply activities contemplated herein and all API supplied hereunder shall comply with the Regulatory Requirements and the Quality Agreement, and all Raw Materials used in the manufacture of API hereunder shall comply with the applicable specifications, Regulatory Requirements, and the Quality Agreement;

(c) Compliance with FFDCA . None of the API supplied to NeurogesX under this Agreement shall be adulterated or misbranded within the meaning of the Act; and

(d) No Encumbrance . Title to all API supplied under this Agreement shall pass as provided in this Agreement, free and clear of any security interest, lien, or other encumbrance.

(e) As of the Effective Date, to its knowledge, Supplier’s method of manufacturing the API does not infringe any patent, trademark, trade secret, or other proprietary rights of third parties to the API.

8.2 NeurogesX Product Warranties . NeurogesX represents and warrants that:

(a) upon marketing authorization NeurogesX is responsible for ensuring that any product incorporating the API conforms to all applicable regulatory and legal requirements and Approvals, and will continue to so conform during the term of this Agreement.

8.3 Recalls . If NeurogesX is required by any regulatory agency to recall the API or if NeurogesX voluntarily initiates a recall of the API and, in either case, if such recall is a result of a breach of any of the warranties set forth in Sections 8.1(a) through 8.1(d) above, Supplier shall bear the out-of-pocket costs of such recall.

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ARTICLE 9

TERM AND TERMINATION

9.1 Term . The term of this Agreement shall commence on the Effective Date and continue in full force until the tenth (10 ^th ) anniversary of the Effective Date, unless terminated earlier in accordance with this Article 9 of this Agreement. This Agreement may be extended for additional two (2)-year periods at NeurogesX’ sole option upon written notice to Supplier at least six (6) months prior to expiration of the then-current term.

9.2 Termination for Breach . Either Party may terminate this Agreement upon written notice in the event that the other Party shall have materially breached this Agreement, and such breach is not cured wi